ModerateClass IITerminated

FDA Devices recall · Reported September 5, 2012

QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2284-2012.

Q: Where was the recalled product distributed?

Distribution: Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV..

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the desig…

Recall #: Z-2284-2012
Affected scope: 64 units
Initiated: August 10, 2012

Compiled from official public sources by the publisher. · Updated September 2026

Verify with FDA Devices →

View my saved recalls

Steris Corporation recalled QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization t… - a moderate-severity action.

QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization t… was recalled by Steris Corporation in September 5, 2012. Reason: STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtai…. Check the official notice for the remedy. Verify recall #Z-2284-2012 with the FDA Devices before acting.

The recall

Steris Corporation issued this moderate-severity FDA Devices recall-STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtai….

Moderate
severity level: 64 units
affected scope: Class II
classification: September 5, 2012
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-2284-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.

Reason for recall

STERIS has been actively seeking devices for quick connect revalidation projects. STERIS was unable to obtain two (2) of the needed devices; these two devices represent the design of seven (7) models in one quick connect. Due to the unavailability of these two validation devices, STERIS will remove 7 models from the labeling of QKC1692E and will re-label all QKC1692Es in the field..

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	Z-2284-2012
Date reported	September 5, 2012
Date initiated	August 10, 2012
Recalling firm	Steris Corporation
Firm location	Mentor, OH
Affected scope	64 units
Distribution	Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

64 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-2284-2012) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

QKC1692E The QKC1692E Quick Connect device connects endoscopes to the sterilization tray for C1220E liquid chemical sterilization processor.. Recalled by Steris Corporation. Units affected: 64 units.

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on September 5, 2012. Severity: Moderate. Recall number: Z-2284-2012.

Where was the recalled product distributed? ▼

Distribution: Nationwide distribution: USA including states of: AR, AK, CA, CO, DE, FL, IL, MA, MD, NC, NE, NH, NY, OH, PA, SD, TN, TX, WI, and WV..

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Leflunomide tablets, 10 mg, a) 30-count b… 2012-09-05 Leflunomide tablets, 20 mg, 1000-count bo… 2012-09-05 Eco-Dent Sparkling Clean Mint Ultimate Es… 2012-09-05 Multihance Multipack (gadobenate dimeglum… 2012-09-05

Similar Medical Devices · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Propofol Injectable Emulsion, 1%, 1 g/100… 2012-09-05 OEC IT3000; IT2500 (EnTrak); IT2500 Plus … 2012-09-05 ON-Q pump with ONDEMAND bolus button, ON-… 2012-09-05 Cisco brand HealthPresence, version 2.1; … 2012-09-05

Compare this recall with GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VS… → · All Medical Devices recalls

This recall: FDA Devices, reported September 5, 2012. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026